Quality Assurance Associate I

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Associate I based onsite in our Tewksbury, MA facility.  CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets.  CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

The Quality Assurance Associate I is responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components in a GMP/ISO Environment.

Requirements

• Perform the review and release of product, including batch record review, review of Quality Control results, Certificate of Analysis creation
• Perform room/line clearances, creation of logbooks and controlled forms and form reconciliations, label review, final inspections
• Review and release of raw materials
• Support CIL’s change control process by helping with the initiation of change control, tracking of documents, and final distribution of the approved documents
• Support the performance of the other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPA’s, document/data review and other administrative duties as needed

• Bachelor's degree in a scientific or quality-related discipline
• Minimum of 0-2 years of experience with Quality Assurance
• Familiarity and/or experience in a GMP environment, along with knowledge of ICH Q7, ISO 17025, and ISO 13485, is a plus
• Must possess strong organizational skills and have a high attention to detail
• Excellent verbal, written, and interpersonal communication skills
• Some travel between Tewksbury, MA and Andover, MA facilities is required as this position supports both locations

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

Cambridge Isotope Laboratories is an Equal Opportunity Employer.

Learn more about us on our website: www.isotope.com

About Us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of stable isotopes and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL’s products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.

We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.

After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.

Learn more about us on our website: www.isotope.com